Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells

Conditions: Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Marginal Zone Lymphoma
Primary Mediastinal B-cell Lymphoma
Diffuse Large B Cell Lymphoma

Brief Summary: The purpose of this study is to assess long-term side effects from subjects who receive an Adicet Bio γδ CAR T cell product. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years from the first administration of Adicet Bio allogeneic γδ CAR T cell product, subjects will be assessed for long-term safety and survival through collection of data that include safety, efficacy, pharmacokinetics and immunogenicity.

Detailed Description: This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who received an Adicet Bio allogeneic γδ CAR T cell product that has been genetically engineered to express the anti-CD20 CAR by transduction with a self-inactivating, replication incompetent gamma retroviral vector. The period of follow-up is 15 years after the administration of the γδ CAR T cell product.

The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to a genetically engineered CAR in Adicet Bio clinical studies. Upon early termination/discontinuation or completion of the parent interventional study, subjects will enroll into this study. Collection of these data will further define the risk-benefit and efficacy profile Adicet allogeneic γδ CAR T cell investigational products.

This is an observational study, and the elements of the study design are per published guidelines for gene therapy medicinal products that utilize integrating viral vectors such as gamma retrovirus and it is important to evaluate any delayed adverse events after infusion with such products.

Recruitment & Eligibility

Inclusion Criteria

All patients who received any Adicet allogeneic CAR T investigational product and have either completed the core treatment protocol or have discontinued early
All patients who are willing and able to adhere to the study visit schedule and other protocol requirements.
Capable of giving signed informed consent which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and protocol

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Subjects from Adicet Bio allogeneic γδ CAR T cell interventional studies.	ADI-001	This is a rollover protocol designed to provide long-term follow-up to all subjects previously enrolled in Adicet Bio allogeneic γδ CAR T cell study. Patients will be followed for up to 15 years post treatment of Adicet Bio allogeneic γδ CAR T cell investigational products.

Primary Outcome Measures

Name	Time	Method
Long-term safety of Adicet Bio allogeneic γδ CAR T cell products	15 years	Occurrence of new Adverse Events of Special interests, Serious AEs and malignancies

Secondary Outcome Measures

Name	Time	Method
Measure quantitative immunoglobulin and peripheral blood immunophenotyping	15 years post last treatment
Monitor for the presence of replication competent retrovirus (RCR)	15 years post last treatment	Test for RCR following treatment with Adicet Bio allogeneic γδ CAR T cell products by QCR analysis
Duration of ADI-001 persistence	15 years post last treatment	Defined as duration from dosing to undetectable levels of Adicet allogeneic γδ CAR T cell per microliter blood
Overall Response Rate by Lugano Criteria	15 years post last treatment	Overall Response Rate by Lugano Criteria
Duration of Response by Lugano Criteria	15 years post last treatment	Duration of Response by Lugano Criteria
Progression Free Survival by Lugano Criteria	15 years post last treatment	Progression Free Survival by Lugano Criteria
Time To Progression by Lugano Criteria	15 years post last treatment	Time To Progression by Lugano Criteria
Overall Survival	15 years post last treatment	Overall Survival from date of first treatment until date of death

Locations (5): Stanford University Medical Center
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Stanford, California, United States
Norton Cancer Institute
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Louisville, Kentucky, United States
Baylor Scott & White Research Institute
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Dallas, Texas, United States
MD Anderson Caner Center
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Houston, Texas, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, United States